Finding the Optimal Resistance Training Exercise for type 2 diabetes

ISRCTN	ISRCTN97865321
DOI	https://doi.org/10.1186/ISRCTN97865321
Protocol serial number	#19581
Sponsor	Toronto Rehabilitation Institute (Canada)
Funders	Toronto Rehabilitation Institute (Canada), Human Physiology Performance Laboratory (Canada), Canadian Diabetes Association (Canada)

Submission date: 14/01/2010
Registration date: 21/06/2010
Last edited: 21/06/2010

Recruitment status: No longer recruiting
Overall study status: Completed
Condition category: Nutritional, Metabolic, Endocrine

Prospectively registered

Protocol

Statistical analysis plan

Results

Individual participant data

Record updated in last year

Plain English summary of protocol

Not provided at time of registration

Contact information

Dr Paul Oh
Scientific

Toronto Rehabilitation Institute
347 Rumsey Rd
Toronto
M4G 1R7
Canada

Study information

Primary study design	Interventional
Study design	Randomised controlled trial
Secondary study design	Randomised controlled trial
Study type	Participant information sheet
Scientific title	Finding the optimal volume and intensity of resistance training exercise for type 2 diabetes: a randomised controlled trial
Study acronym	The FORTE Study
Study objectives	A higher intensity, hypertrophic resistance training protocol added to aerobic training would lead to more marked improvements to glycaemic control and cardiovascular risk factors compared to lower intensity endurance training.
Ethics approval(s)	University of Toronto Research Ethics Board (REB) approved in February 2006 (ref: 19581)
Health condition(s) or problem(s) studied	Type 2 diabetes
Intervention	Six months of aerobic and resistance training: 1. Aerobic training and minimal resistance training (usual care) 2. Aerobic training and high intensity resistance training 3. Aerobic training and low intensity resistance training The intervention for all groups was 6 months. Following completion of the program, patients will not be followed-up.
Intervention type	Other
Primary outcome measure(s)	Measured at baseline and 6 months: 1. HbA1c 2. Maximal aerobic power (VO2 max)
Key secondary outcome measure(s)	Measured at baseline and 6 months: 1. Fasting glucose 2. Insulin 3. Proinsulin 4. Blood lipid profile 5. Body composition (dual energy x-ray absorptiometry [DEXA]) 6. Cytokines (interleukin-6 [IL-6], interleukin-1B [IL-1B], c-reactive protein [CRP]) 7. Adipokines (tumour necrotising factor-alpha [TNF-alpha], adiponectin, leptin, leptin receptor) 8. Depressive mood (Center for Epidemiologic Studies Depression Scale [CESD]) 9. Quality of life (Diabetes Quality of Life Clinical Trial Questionnaire [DSQLQ]) 10. Nutrition intake
Completion date	31/03/2009

Eligibility

Participant type(s)	Patient
Age group	Adult
Lower age limit	18 Years
Sex	All
Target sample size at registration	120
Key inclusion criteria	1. Adults aged greater than 18 years, either sex 2. Type 2 Diabetes 3. Participating in the Diabetes Exercise and Healthy Lifestyle Program of the Toronto Rehabilitation Institute
Key exclusion criteria	1. History of diagnosed cardiovascular disease 2. Contraindications to high intensity exercise participation: 2.1. Glaucoma 2.2. Retinopathy 2.3. Musculoskeletal limitations 2.4. Kidney disease 2.5. Balance impairments
Date of first enrolment	01/05/2006
Date of final enrolment	31/03/2009

Locations

Countries of recruitment

Canada

Study participating centre

Toronto Rehabilitation Institute

Toronto
M4G 1R7
Canada

Results and Publications

Individual participant data (IPD) Intention to share	No
IPD sharing plan summary	Not provided at time of registration
IPD sharing plan

Study outputs

Output type	Details	Date created	Date added	Peer reviewed?	Patient-facing?
Participant information sheet	Participant information sheet	11/11/2025	11/11/2025	No	Yes